Ingelvac PCV FLEX

Table of contents

Overview

This is a summary of the European public assessment report (EPAR) for Ingelvac PCV Flex.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Ingelvac PCV Flex.

For practical information about using Ingelvac PCV Flex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Ingelvac PCV Flex is a vaccine used to protect pigs from two weeks of age against porcine circovirus type 2 (PCV2). Ingelvac PCV Flex is to be used in pigs which have no maternally derived antibodies (a special type of proteins, received from the mother in the milk that help the body to fight infection) to PCV2. PCV2 infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin). Ingelvac PCV Flex contains the active substance porcine circovirus type 2 ORF2 protein.

This medicine is the same as Ingelvac CircoFLEX, which is already authorised in the European Union (EU). The company that makes Ingelvac CircoFLEX has agreed that its scientific data can be used for Ingelvac PCV Flex (‘informed consent’).

Ingelvac PCV Flex is available as a suspension for injection and can only be obtained with a prescription. It is given by injection into the muscle as a single dose. The vaccine starts to be effective 2 weeks after vaccination and protection lasts for 17 weeks.

Ingelvac PCV Flex is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Ingelvac PCV Flex contains small amounts of a protein from PCV2. When a pig is given the vaccine, the pig’s immune system recognises the protein as ‘foreign’ and reacts by building up an active immune response. In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus. This active immune response will help to protect the pig against the disease caused by this virus.

Ingelvac PCV Flex has been studied in a number of trials involving pigs of various breeds. These studies were performed under laboratory as well as under typical European farming conditions. The trials showed that vaccination of pigs (which had no antibodies to PCV2 before vaccination) with Ingelvac PCV Flex reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, virus excreted from the nose and death rates.

The most common side effect with Ingelvac PCV Flex (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.

For the full list of restrictions and all side effects reported with Ingelvac PCV Flex, see the package leaflet.

No special precautions are required.

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.

The withdrawal period for meat from pigs treated with Ingelvac PCV Flex is ‘zero days’, which means there is no mandatory waiting time.